Parenteral treatments involving aminoadamantane derivatives

Inventors

Singh Sachdeva, Gurpartap • Borsadia, Suresh • Patel, Kalpana • RAVAL, Krunal

Assignees

Shinkei Therapeutics Inc

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Publication Number

US-11707439-B2

Patent

Publication Date

2023-07-25

Expiration Date


Abstract

A method and composition is described for treating impaired neurological function, CNS disease or condition, including altered state of consciousness disorders in a human subject, comprising parenterally administering a composition comprising aminoadamantane derivatives or salts thereof, alone or in combination with other neuroprotective and/or anti-inflammatory compounds, in a pharmacologically effective amount. In some embodiments, a method for treating traumatic brain injury caused by a stroke or an accident in a human subject is provided comprising intravenously administering a composition comprising amantadine hydrochloride in a pharmacologically effective amount to the subject in need thereof.

Core Innovation

The invention relates to methods of treating traumatic brain injury in a human subject using parenteral administration of an aminoadamantane derivative. In particular, it provides intravenous administration of a composition consisting of a pharmacologically effective amount of amantadine or a pharmaceutically acceptable salt thereof in sterile water, free of any other excipients.

The composition is administered once or twice daily at a daily dose of about 200 mg to about 400 mg of amantadine or a pharmaceutically acceptable salt, with an administration rate of about 15 mg/hr to about 135 mg/hr. The composition has a volume of about 100 ml to about 1000 ml.

For traumatic brain injury, the invention encompasses treating mild and severe traumatic brain injury, including severe-associated conditions such as coma, vegetative state, minimally conscious state, and disorder of consciousness. The disclosed approach also allows co-therapy in which a neuroprotective and/or anti-inflammatory compound is administered in combination with the amantadine-containing composition.

Claims Coverage

The partial content includes two independent claims. Each independent claim focuses on an intravenous sterile-water composition of an amantadine compound with defined dosing and administration parameters for traumatic brain injury.

Intravenous sterile-water amantadine composition without other excipients for traumatic brain injury

A method of treating traumatic brain injury in a human subject comprising intravenously administering a composition consisting of a pharmacologically effective amount of amantadine or a pharmaceutically acceptable salt thereof in sterile water and wherein the composition is free of any other excipients.

Once or twice daily intravenous dosing at defined daily dose, infusion rate, and composition volume for traumatic brain injury

The intravenous composition has a volume of about 100 ml to about 1000 ml and is administered once or twice daily at a daily dose of about 200 mg to about 400 mg amantadine (or a pharmaceutically acceptable salt) at a rate of about 15 mg/hr to about 135 mg/hr.

Intravenous amantadine hydrochloride in sterile water for mild or severe traumatic brain injury with specified dosing and administration parameters

A method of treating mild or severe traumatic brain injury in a human subject comprising intravenously administering a composition consisting of a daily dosage of about 200 mg to about 400 mg of amantadine hydrochloride in sterile water, administered at a rate of about 15 mg/hr to about 135 mg/hr.

Once or twice daily intravenous amantadine hydrochloride dosing with defined composition volume

The composition has a volume of about 100 ml to about 1000 ml and is administered once or twice daily.

Across the independent claims, coverage is directed to intravenous treatment of traumatic brain injury using a sterile-water composition containing amantadine or amantadine hydrochloride without other excipients, with defined daily dose, administration rate, and composition volume, administered once or twice daily.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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